Tagged Articles

moderate risk 11 articles

Consumer Reports chief protests medical device approval process

“It’s a nightmare scenario,” Consumer Reports President Jim Guest wrote in an email blast to one million Americans earlier this year. He was warning consumers that medical devices they assume are safe may not be fully vetted before being approved by the Food and Drug Administration (FDA), and that the federal government needed to change this process that is putting the lives of millions of people at risk. Guest was speaking out against a long-used practice of the FDA in which so-called moderate risk medical devices are approved quickly without testing to prove they are safe and effective if similar ... Read More

Consumers Union fights for more oversight of medical devices

The Consumers Union (CU) is hoping to close a loophole in the approvals of medical devices that allows them to be cleared for marketing in the United States with almost no government regulation, testing or monitoring. According to its mission statement, CU is an expert, independent, nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CU also publishes the magazine Consumer Reports and the website ConsumerReports.org. Currently, medical devices considered moderate-risk, such as transvaginal mesh and artificial hips, are approved through an accelerated process that ... Read More

Consumer groups question safety of expedited medical device approvals

Medical device manufacturers spent more than $33 million last year and used 225 lobbyists to pressure lawmakers to support the Food and Drug Administration’s current practice of allowing moderate-risk devices to be approved without thorough testing for safety and efficacy. The practice has come under fire in recent months, in particular by consumer groups who argue that the agency’s expedited approval process puts patients at risk for serious injury or death. This debate is currently being weighed by members of congress, who will also consider the FDA’s proposal to remedy the situation. The agency is proposing a fee increase for ... Read More

Congress considers medical device approval process

Members of Congress are debating this week whether to speed up the approval process for moderate-risk medical devices to help patients in need even if it puts those patients’ lives at risk. The hearing bring to light a highly debated topic, and one that is pitting medical device manufacturers against consumer groups. These consumer groups include people like Lena Keeton, who nearly died after contracting a flesh-eating bacteria following surgery in 2001 during which she received surgical mesh to treat occasional incontinence. Overcoming the bacterial infection was only part of Keeton’s ordeal. Over the next decade, she has undergone 17 ... Read More

Medical device makers to pay more for product safety reviews

The Food and Drug Administration (FDA) is doubling its fees to medical device makers who want their products reviewed in order to market them in the United States. The increase will allow the federal agency to hire 200 new full-time employees to carry out more detailed reviews and allow more time for device manufacturers to address concerns about safety issues. The fee increase, which will first have to be approved by Congress, comes just months after the agency’s accelerated approval process for moderate-risk medical devices was criticized for allowing medical devices to be marketed without adequate testing, putting the public’s ... Read More

FDA increases fees in hopes of improving medical device approval process

Medical device manufacturers will have to double the fees they pay to the Food and Drug Administration (FDA) in order to have their products reviewed over the next five years as part of a plan to provide faster, more thorough evaluations. The increase would allow the FDA to hire 200 new full-time employees within five years to assist with medical device evaluations. As part of the approval process, evaluators would be required to meet with device applicants midway through the review process in order to address concerns. Medical device makers are in favor of a plan that would allow for ... Read More

Transvaginal mesh maker profiting despite mounting lawsuits

C.R. Bard Inc. is rolling in higher profits after postings its third quarter results, but the celebration may be short lived. The medical device company is facing dozens of lawsuits from patients who have asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products, namely its Avaulta transvaginal mesh. The multi-district litigation, consolidated from 21 individual lawsuits earlier this fall, includes complaints from women who received three different types of Avaulta mesh – Avaulta Biosynthetic, Avaulta Plus, and Avaulta Solo mesh. Earlier this year, 29 other women who had previously filed lawsuits against ... Read More

FDA focuses on safety and innovation in approval of medical devices

Amid pressure from victims of faulty artificial hips and an independent medical policy group to stiffen the approval process for medical devices, and requests from medical device manufacturers to keep the status quo, the top device official for the Food and Drug Administration (FDA) told industry executives last month that the agency hopes to find a solution that focuses both on safety and innovation. The approval process for moderate risk medical devices, such as artificial hips and surgical mesh, has become the focus of concern for the agency after last year’s recall of the DePuy ASR XL Acetabular Hip Replacement ... Read More

House Democrats push for closer review of metal-on-metal hip implants

House Republicans are being urged by Democrats to investigate the safety of metal-on-metal artificial hips, such as the recalled DePuy Orthopaedics ASR XL systems, and the process by which those devices are approved. The request was made by Energy and Commerce Committee chairman Rep. Henry Waxman of California. Hip implants are typically made from ceramic or plastic parts. But some newer varieties are constructed with metal-on-metal parts. This design is intended to be more durable and last longer than traditional implants. Instead, they have been found to fail at a higher than expected rate. Metal-on-metal hip implants involve a metal ball ... Read More

FDA launches new training program for medical device reviewers

The Food and Drug Administration (FDA) has implemented two new training programs designed to improve the consistency of medical device reviews by enhancing the skills of the individuals tasked with reviewing pre-marketing applications at the agency’s Center for Devices and Radiological Health (CDRH). This program is just one of the 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Science Recommendations announced earlier this year to increase the predictability and transparency of regulatory pathways and to strengthen the 510(k) process, an expedited approval process granted to moderate-risk medical devices determined to be “sufficiently similar” ... Read More